5 mL LL 21 Ga. x 1 in.

5 mL LL 21 Ga. x 1 in.
Omnifix™ - 4610522-02

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

No Data Available

• Total Volume: 5.0 Milliliter
• Gauge (cannula) : 21

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FMI

Device Name: Needle, Hypodermic, Single Lumen

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5570

Third Party Flag: Y

Medical Specialty: HO

Code: FMF

Device Name: Syringe, Piston

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5860

Third Party Flag: Y

Medical Specialty: HO

Device Id: 04046963442309

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04046963441999

Package Quantity: 9

Package Discontinue Date: 4/4/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton

Device Id: 04046963441999

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 04046964332401

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A